# FDA recall Z-1833-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-08-16.

## Product

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire  Reference Part Number/GPN:  TSCF-25-180-3	G01602  TSCF-35-180-3	G00902  TSCF-21-260-3	G00455  THSCF-25-260-3	G02384  TSCF-25-145-3	G00466  THSCF-35-80-3	G04069  THSCF-35-180-15	G01151  TSCF-21-50-3	G00456  THSCF-35-145-3	G00412  TSCF-35-145-15	G00509  TSCF-35-145-1.5	G00507  TSCF-35-145-3	G00511  TSCF-38-80-3	G00552  TSCF-18-180-3	G02160  TSCF-35-80-3	G00529  TSCF-21-180-3	G01793  TSCF-25-260-3	G00471  C-SCF-18-50-3	G02050  C-SCF-18-40-2	G02659  C-SCF-25-50-3	G02180  TSCF-18-80-3	G00441  C-SCF-15-30-2	G06973

## Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1833-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-16
- **Report date:** 2022-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2022

## Citation

> AI Analytics. FDA recall Z-1833-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1833-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*